Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT06847334
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of stage IV inoperable to surgery or radiotherapy (AJCC 8th edition) non-squamous NSCLC.
* Without any tumor activating EGFR mutation or ALK or ROS1 gene rearrangement.
* Have not received prior systemic treatment for their advanced/metastatic NSCLC.
* At least one measurable lesion as assessed by IRRC based on RECIST v1.1.
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
* Have adequate organ function.
Exclusion Criteria:
* Subjects with NSCLC of other histopathological types, such as mixed adenosquamous carcinoma, and subjects with small cell lung cancer or neuroendocrine carcinoma.
* Subjects with other active malignancies within 5 years or at the same time prior to screening.
* Active central nervous system metastases.
* Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity.
* Known active or suspected autoimmune diseases.
* History of immunodeficiency, including HIV antibody positive, active hepatitis B; or hepatitis C virus infections.
* Have received pembrolizumab or any other immune checkpoints inhibitors (PD-1, PD-L1, CTLA4, etc.) before screening.
* Pregnant or breastfeeding female.
* The investigator has a clear reason to believe that participation in this study would be detrimental to the subject.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06847334
Study Brief:
Protocol Section:
NCT06847334